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Senior Product Assessor

Senior Product Assessor

VirtualVocationsGary, Indiana, United States
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A company is looking for a Senior Product Assessor, Active Devices.

Key Responsibilities

Support and guide a team of Product Assessors

Conduct technical documentation reviews ensuring compliance with EU regulations

Collaborate with cross-functional teams to enhance efficiency and quality

Required Qualifications

Four years of professional experience in healthcare products or related activities

Knowledge of Active Medical Devices through design, manufacturing, or testing

Thorough understanding of related standards such as EN 60601, EN 62304, EN 62366

Mandatory knowledge of Technical File codes MDA 0304 & MDA 0314

Good written English skills for report review and queries

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Assessor • Gary, Indiana, United States

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